BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3201195 · Received July 2, 2013

    Report

    Report Number
    3005477969-2013-00260
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 26, 2013
    Report Date
    February 21, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303282 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 08HW18239

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R MODULAR HEAD SLEEVE PART #74222400, LOT #07KW14460| FEMORAL HEAD, PART# 74222144, LOT# 09EW23421